Establishing Effectiveness for Drugs Intended To Treat Male Hypogonadotropic Hypogonadism Attributed to Nonstructural Disorders; Guidance for Industry; Availability, 23461-23463 [2018-10732]
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Federal Register / Vol. 83, No. 98 / Monday, May 21, 2018 / Notices
with BP in a Consent Decree approved
by the United States District Court for
the Eastern District of Louisiana.
Pursuant to that Consent Decree,
restoration projects in the Louisiana
Restoration Area are now chosen and
managed by the Louisiana TIG. The
Louisiana TIG is composed of the
following Trustees: CPRA, LOSCO,
LDEQ, LDWF, LDNR, EPA, DOI, NOAA,
USDA.
sradovich on DSK3GMQ082PROD with NOTICES
Background
In the December 2017 Draft RP/EA #2,
the Louisiana TIG presented to the
public its plan for providing partial
compensation for recreational use
services lost as a result of the Deepwater
Horizon oil spill. The public comment
period for the Draft RP/EA #2 began on
December 20, 2017, and closed on
February 2, 2018. The Louisiana TIG
hosted a public meeting on January 24,
2018, in New Orleans. The Draft RP/EA
#2 proposed four restoration projects,
evaluated in accordance with OPA and
NEPA, including the Elmer’s Island
Access project. As proposed, the Elmer’s
Island Access project would enhance
recreational opportunities within the
Elmer’s Island Refuge by incorporating
a suite of features to improve upon
existing access points, enhance the
natural features of the area through
reconnected hydrology, and develop a
solution for improved access for
recreational fishing activities targeting
the eastern portion of Elmer’s Island
adjacent to Caminada Pass. In response
to the public comments received on the
Elmer’s Island Access project proposed
in the Draft RP/EA #2, the Louisiana
TIG is proposing a modification to the
original project feature. This
modification would eliminate the
proposed boardwalk and associated
small boat launch and parking area at
Elmer’s Island, and provide a beach
shuttle service that would allow
improved public access to Caminada
Pass, the most popular location for
recreational fishing on Elmer’s Island.
The Louisiana TIG has prepared the
Draft Supplemental RP/EA to inform the
public about the proposed modification
to the Elmer’s Island Access project and
to seek public comment.
Next Steps
The public is encouraged to review
and comment on the Draft
Supplemental RP/EA. A public meeting
is scheduled to also help facilitate the
public review and comment process.
Comments provided on the Draft
Supplemental RP/EA will be considered
along with comments previously
received on the Draft RP/EA #2. A
summary of comments received on the
VerDate Sep<11>2014
18:20 May 18, 2018
Jkt 244001
Draft Supplemental RP/EA and the Draft
RP/EA #2 and the Louisiana TIG’s
responses, where applicable, will be
included in the Final Restoration Plan/
Environmental Assessment #2: Provide
and Enhance Recreational Opportunities
(Final RP/EA #2). Public comments on
the Draft Supplemental RP/EA will
inform the Louisiana TIG’s decision on
whether to select the Elmer’s Island
Access project, as modified, in the Final
RP/EA #2.
Administrative Record
The documents comprising the
Administrative Record for the Draft
Supplemental RP/EA can be viewed
electronically at https://www.doi.gov/
deepwaterhorizon/administrativerecord.
Authority
The authority for this action is the Oil
Pollution Act of 1990 (33 U.S.C. 2701 et
seq.), its implementing NRDA
regulations found at 15 CFR part 990,
and NEPA (42 U.S.C. 4321 et seq.).
Dated: May 3, 2018.
Benita Best-Wong,
Acting Principal Deputy Assistant
Administrator, Office of Water.
[FR Doc. 2018–10112 Filed 5–18–18; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
[ER–FRL–9039–04–OP]
Environmental Impact Statements;
Notice of Availability
Responsible Agency: Office of Federal
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564–7156 or https://
www2.epa.gov/nepa/.
Weekly receipt of Environmental Impact
Statements
Filed 05/07/2018 Through 05/11/2018
Pursuant to 40 CFR 1506.9
Notice
Section 309(a) of the Clean Air Act
requires that EPA make public its
comments on EISs issued by other
Federal agencies. EPA’s comment letters
on EISs are available at: https://
cdxnodengn.epa.gov/cdx-nepa-public/
action/eis/search.
EIS No. 20180095, Final, USFWS, CA,
Final Environmental Impact
Statement/Environmental Impact
Report for the South Sacramento
Habitat Conservation Plan, Review
Period Ends: 06/21/2018, Contact:
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Impact Report/Land Use Plan
Amendment, Review Period Ends: 06/
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EIS No. 20180097, Final, USFS, CO,
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Review Period Ends: 06/21/2018,
Contact: Deborah Kill 970–882–6822.
EIS No. 20180098, Final, USFS, MT,
Starry Goat, Review Period Ends: 06/
21/2018, Contact: Lisa Osborn 406–
295–7426.
EIS No. 20180099, Draft, FAA, AZ,
Tucson International Airport—
Airfield Safety Enhancement Project,
Comment Period Ends: 07/09/2018,
Contact: David B. Kessler, AICP 310–
725–3615.
EIS No. 20180100, Final, USFS, CO, P
District-wide Salvage Project, Review
Period Ends: 07/05/2018, Contact:
Mike Tooley 719–274–6321.
EIS No. 20180101, Draft Supplement,
Caltrans, CA, SR 710 North Study
FRDEIR/SDEIS_05–09–18, Comment
Period Ends: 07/05/2018, Contact:
Jason Roach 213–897–0357.
EIS No. 20180102, Draft, NMFS, FL,
Coral Habitat Areas Considered for
Habitat Areas of Particular Concern
Designation in the Gulf of Mexico,
Comment Period Ends: 07/05/2018,
Contact: Lauren Waters 727–209–
5991.
EIS No. 20180103, Final, USFWS, CA,
Otay River Estuary Restoration
Project, South San Diego Bay Unit of
the San Diego Bay National Wildlife
Refuge, California, Final
Environmental Impact Statement,
Review Period Ends:
06/21/2018, Contact: Brian Collins
619–575–2704.
Dated: May 17, 2018.
Brittany Bolen,
Acting Assistant Administrator, Office of
Policy.
[FR Doc. 2018–10937 Filed 5–18–18; 8:45 am]
BILLING CODE 6560–50–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–D–6759]
Establishing Effectiveness for Drugs
Intended To Treat Male
Hypogonadotropic Hypogonadism
Attributed to Nonstructural Disorders;
Guidance for Industry; Availability
AGENCY:
Food and Drug Administration,
HHS.
E:\FR\FM\21MYN1.SGM
21MYN1
23462
ACTION:
Federal Register / Vol. 83, No. 98 / Monday, May 21, 2018 / Notices
Written/Paper Submissions
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a
guidance for industry entitled
‘‘Establishing Effectiveness for Drugs
Intended to Treat Male
Hypogonadotropic Hypogonadism
Attributed to Nonstructural Disorders.’’
This guidance provides
recommendations for establishing
clinical effectiveness for drugs intended
to treat male hypogonadotropic
hypogonadism associated with obesity
and other conditions that do not cause
structural disorders of the
hypothalamus or pituitary gland. This
guidance incorporates advice FDA
received at a December 2014 advisory
committee meeting on the appropriate
indicated population for testosterone
therapy and a December 2016 advisory
committee meeting on
hypogonadotropic hypogonadism. This
guidance finalizes the draft guidance of
the same name issued on January 3,
2018.
SUMMARY:
The announcement of the
guidance is published in the Federal
Register on May 21, 2018.
DATES:
You may submit either
electronic or written comments on
Agency guidances at any time as
follows:
ADDRESSES:
sradovich on DSK3GMQ082PROD with NOTICES
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
VerDate Sep<11>2014
18:20 May 18, 2018
Jkt 244001
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2017–D–6759 for ‘‘Establishing
Effectiveness for Drugs Intended to
Treat Male Hypogonadotropic
Hypogonadism Attributed to
Nonstructural Disorders; Guidance for
Industry; Availability.’’ Received
comments will be placed in the docket
and, except for those submitted as
‘‘Confidential Submissions,’’ publicly
viewable at https://www.regulations.gov
or at the Dockets Management Staff
between 9 a.m. and 4 p.m., Monday
through Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your comments and you
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with 21 CFR 10.20
and other applicable disclosure law. For
more information about FDA’s posting
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
the information at: https://www.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf.
Docket: For access to the docket to
read background documents or the
PO 00000
Frm 00049
Fmt 4703
Sfmt 4703
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.
You may submit comments on any
guidance at any time (see 21 CFR
10.115(g)(5)).
Submit written requests for single
copies of this guidance to the Division
of Drug Information, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10001 New
Hampshire Ave, Hillandale Building,
4th Floor, Silver Spring, MD 20993–
0002. Send one self-addressed adhesive
label to assist that office in processing
your requests. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the guidance document.
FOR FURTHER INFORMATION CONTACT:
Jeannie Roule, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave, Bldg. 22, Rm. 5332,
Silver Spring, MD 20993–0002, 301–
796–3993.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a guidance for industry entitled
‘‘Establishing Effectiveness for Drugs
Intended to Treat Male
Hypogonadotropic Hypogonadism
Attributed to Nonstructural Disorders.’’
This guidance provides
recommendations for establishing
clinical effectiveness for drugs intended
to treat male hypogonadotropic
hypogonadism associated with obesity
and other conditions that do not cause
structural disorders of the
hypothalamus or pituitary gland. This
guidance incorporates advice FDA
received at a December 2014 advisory
committee meeting on the appropriate
indicated population for testosterone
therapy and a December 2016 advisory
committee meeting on
hypogonadotropic hypogonadism. This
guidance finalizes the draft guidance of
the same name issued on January 3,
2018 (83 FR 383). The guidance
includes editorial changes and a new
sentence clarifying that the
recommendations do not apply to
testosterones and testosterone esters
seeking the traditional indication of
replacement therapy in adult males for
conditions associated with a deficiency
or absence of endogenous testosterone.
This guidance is being issued
consistent with FDA’s good guidance
E:\FR\FM\21MYN1.SGM
21MYN1
Federal Register / Vol. 83, No. 98 / Monday, May 21, 2018 / Notices
practices regulation (21 CFR 10.115).
The guidance represents the current
thinking of FDA on establishing
effectiveness for drugs intended to treat
male hypogonadotropic hypogonadism
attributed to nonstructural disorders. It
does not establish any rights for any
person and is not binding on FDA or the
public. You can use an alternative
approach if it satisfies the requirements
of the applicable statutes and
regulations. This guidance is not subject
to Executive Order 12866.
II. Electronic Access
Persons with access to the internet
may obtain the guidance at either
https://www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm or https://
www.regulations.gov.
Dated: May 15, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–10732 Filed 5–18–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Cytomegalovirus in Transplantation:
Developing Drugs To Treat or Prevent
Disease; Draft Guidance for Industry;
Availability
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a draft
guidance for industry entitled
‘‘Cytomegalovirus in Transplantation:
Developing Drugs to Treat or Prevent
Disease.’’ The purpose of this guidance
is to assist sponsors in all phases of
development of drugs and biologics for
the treatment or prevention of
cytomegalovirus (CMV) disease in
patients who have undergone solid
organ transplantation (SOT) or
hematopoietic stem cell transplantation
(HSCT).
sradovich on DSK3GMQ082PROD with NOTICES
SUMMARY:
Submit either electronic or
written comments on the draft guidance
by July 20, 2018 to ensure that the
Agency considers your comment on this
draft guidance before it begins work on
the final version of the guidance.
DATES:
You may submit comments
on any guidance at any time as follows:
ADDRESSES:
VerDate Sep<11>2014
18:20 May 18, 2018
Jkt 244001
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
[Docket No. FDA 2018–D–1711]
AGENCY:
Electronic Submissions
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA 2018–
D–1711 for ‘‘Cytomegalovirus in
Transplantation: Developing Drugs to
Treat or Prevent Disease; Draft Guidance
for Industry; Availability.’’ Received
comments will be placed in the docket
and, except for those submitted as
‘‘Confidential Submissions,’’ publicly
viewable at https://www.regulations.gov
or at the Dockets Management Staff
between 9 a.m. and 4 p.m., Monday
through Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
PO 00000
Frm 00050
Fmt 4703
Sfmt 4703
23463
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your comments and you
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with 21 CFR 10.20
and other applicable disclosure law. For
more information about FDA’s posting
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
the information at: https://www.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.
You may submit comments on any
guidance at any time (see 21 CFR
10.115(g)(5)).
Submit written requests for single
copies of the draft guidance to the
Division of Drug Information, Center for
Drug Evaluation and Research, Food
and Drug Administration, 10001 New
Hampshire Ave., Hillandale Building,
4th Floor, Silver Spring, MD 20993–
0002. Send one self-addressed adhesive
label to assist that office in processing
your requests. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the draft guidance document.
FOR FURTHER INFORMATION CONTACT:
Jeffrey Murray, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 6360,
Silver Spring, MD 20993–0002, 301–
796–1500.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a draft guidance for industry entitled
‘‘Cytomegalovirus in Transplantation:
Developing Drugs to Treat or Prevent
E:\FR\FM\21MYN1.SGM
21MYN1
Agencies
[Federal Register Volume 83, Number 98 (Monday, May 21, 2018)]
[Notices]
[Pages 23461-23463]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-10732]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2017-D-6759]
Establishing Effectiveness for Drugs Intended To Treat Male
Hypogonadotropic Hypogonadism Attributed to Nonstructural Disorders;
Guidance for Industry; Availability
AGENCY: Food and Drug Administration, HHS.
[[Page 23462]]
ACTION: Notice of availability.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a guidance for industry entitled ``Establishing
Effectiveness for Drugs Intended to Treat Male Hypogonadotropic
Hypogonadism Attributed to Nonstructural Disorders.'' This guidance
provides recommendations for establishing clinical effectiveness for
drugs intended to treat male hypogonadotropic hypogonadism associated
with obesity and other conditions that do not cause structural
disorders of the hypothalamus or pituitary gland. This guidance
incorporates advice FDA received at a December 2014 advisory committee
meeting on the appropriate indicated population for testosterone
therapy and a December 2016 advisory committee meeting on
hypogonadotropic hypogonadism. This guidance finalizes the draft
guidance of the same name issued on January 3, 2018.
DATES: The announcement of the guidance is published in the Federal
Register on May 21, 2018.
ADDRESSES: You may submit either electronic or written comments on
Agency guidances at any time as follows:
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2017-D-6759 for ``Establishing Effectiveness for Drugs Intended to
Treat Male Hypogonadotropic Hypogonadism Attributed to Nonstructural
Disorders; Guidance for Industry; Availability.'' Received comments
will be placed in the docket and, except for those submitted as
``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
Submit written requests for single copies of this guidance to the
Division of Drug Information, Center for Drug Evaluation and Research,
Food and Drug Administration, 10001 New Hampshire Ave, Hillandale
Building, 4th Floor, Silver Spring, MD 20993-0002. Send one self-
addressed adhesive label to assist that office in processing your
requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the guidance document.
FOR FURTHER INFORMATION CONTACT: Jeannie Roule, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave, Bldg. 22, Rm. 5332, Silver Spring, MD 20993-0002, 301-
796-3993.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a guidance for industry
entitled ``Establishing Effectiveness for Drugs Intended to Treat Male
Hypogonadotropic Hypogonadism Attributed to Nonstructural Disorders.''
This guidance provides recommendations for establishing clinical
effectiveness for drugs intended to treat male hypogonadotropic
hypogonadism associated with obesity and other conditions that do not
cause structural disorders of the hypothalamus or pituitary gland. This
guidance incorporates advice FDA received at a December 2014 advisory
committee meeting on the appropriate indicated population for
testosterone therapy and a December 2016 advisory committee meeting on
hypogonadotropic hypogonadism. This guidance finalizes the draft
guidance of the same name issued on January 3, 2018 (83 FR 383). The
guidance includes editorial changes and a new sentence clarifying that
the recommendations do not apply to testosterones and testosterone
esters seeking the traditional indication of replacement therapy in
adult males for conditions associated with a deficiency or absence of
endogenous testosterone.
This guidance is being issued consistent with FDA's good guidance
[[Page 23463]]
practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA on establishing effectiveness for drugs
intended to treat male hypogonadotropic hypogonadism attributed to
nonstructural disorders. It does not establish any rights for any
person and is not binding on FDA or the public. You can use an
alternative approach if it satisfies the requirements of the applicable
statutes and regulations. This guidance is not subject to Executive
Order 12866.
II. Electronic Access
Persons with access to the internet may obtain the guidance at
either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or
https://www.regulations.gov.
Dated: May 15, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-10732 Filed 5-18-18; 8:45 am]
BILLING CODE 4164-01-P